Bladder Cancer

Merck’s pembrolizumab receives approval in Japan for treatment of pts with unresectable UC progressing after chemo

Merck announces that pembrolizumab (Keytruda), an anti–programmed cell death-1 (PD-1) therapy, has been approved in Japan for the treatment of patients with radically unresectable urothelial carcinoma (UC) who experienced progression after cancer chemotherapy. The approval is based on data from the phase III KEYNOTE-045 trial, which demonstrated superior overall survival for pembrolizumab vs investigator-choice chemotherapy (paclitaxel, docetaxel, and vinflunine; HR = 0.73 [95% CI: 0.59–0.91], P = .002). With this approval, pembrolizumab is now indicated for use in 4 types of cancer in Japan, including for the treatment of radically unresectable melanoma, PD-(ligand)1–positive unresectable advanced or recurrent non-small cell lung cancer, and relapsed or refractory classical Hodgkin lymphoma.

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